Cold and Flu
- Product NDC
- 49035-053
- 11-digit product format
- 490350053
- Labeler code
- 49035
- Product ID
- 49035-053_40621759-f1e2-4dc6-9f26-726a82e19b40
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Wal-Mart Stores Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-08-04
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold and Flu
- Brand name suffix
- severe
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1110988 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49035-053-08 | Cold and Flusevere | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 15 |
| 49035-053-08 | Cold and Flusevere | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 15 |
| 49035-053-42 | Cold and Flusevere | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49035-053 | COLD AND FLU SEVERE (ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) TABLET, FILM COATED [WAL-MART STORES INC] | 14 | Current NDC, Legacy NDC, 3 package rows | 20250519_9fca25dc-f63e-487a-8b7c-84d65ea51cb5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49035-053-08 | 49035005308 | 2 BLISTER PACK in 1 CARTON (49035-053-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2005-08-04 | 0000-00-00 | No | No | Current |
| 49035-053-42 | 49035005342 | 12 TABLET, FILM COATED in 1 BLISTER PACK (49035-053-42) | | 2005-08-04 | 0000-00-00 | No | No | Current |